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It’s probably not whether the “test” is or is not of value but how they are performed, and in context of Path QA review, “well-evidenced QA”. The recommendations in the BIVDA document P5 are worth thinking about - http://www.bivda.co.uk/Portals/0/Documents/Policy%20and%20Media/Inhouse%20audit%20Aug%2013.pdf The thing around CE marking is that it should give a consistency of product performance……..although we can all name products where that consistency seems to be very lacking even with CE mark! If we are using POCT [or any other test] outside of CE mark, perhaps we should at least be able to assess its performance [presumably there is some form of QA being done to make sure that sensitivity is consistent??] on a day to day basis, and over period of time? I can’t see any manufacturer doing the necessary validation for every conceivable fluid, so there will be use of IVDs outside of CE marking – is the issue how we evidence that they are being used within a defined protocol and performing as has been specified in that context?? dj From: Clinical biochemistry discussion list [mailto:[log in to unmask]] On Behalf Of Iversen Andrew (BRIGHTON AND SUSSEX UNIVERSITY HOSPITALS NHS TRUST) Sent: 20 March 2014 16:23 To: [log in to unmask] Subject: Re: Unexpected use for POCT device for FOB --- This message was sent from an email address external to NHSmail but gives the appearance of being from an NHSmail (@nhs.net) address. The recipient should verify the sender and content before acting upon information contained within. The identified sender is [log in to unmask]<mailto:[log in to unmask]> --- Although of course the test should be CE marked and validated, the test is very sensitive and is better than microscopy for red cells (at least in urine). Interferences are possible, but in view of the paper that Jonathan posted then as a simple pre-op assessment perhaps there might just be some merit in it? Andrew ________________________________ From: Clinical biochemistry discussion list [mailto:[log in to unmask]] On Behalf Of Jonathan Kay Sent: 20 March 2014 14:23 To: [log in to unmask]<mailto:[log in to unmask]> Subject: Re: Unexpected use for POCT device for FOB Does it work? http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1352979/pdf/annsurg00142-0031.pdf Jonathan On 20 Mar 2014, at 13:43, Tetlow Tony <[log in to unmask]<mailto:[log in to unmask]>> wrote: Dear Collective I wish to access the group wisdom over a use for POCT testing device in breast clinics which I have never come across. The background is that we are having a conversation about POCT devices pre colonoscopy. An email with the following statement cropped up: “The breast clinic also use these fob testing strips to detect blood in nipples that are discharging. We have been using these since i have been here and that must be 8 years now ?” Never come across this before and was stunned. Could I please have your thoughts on this. Best wishes Tony Mr Tony Tetlow BSc, MSc, DipCB, FRCPath Consultant Clinical Scientist Tameside Hospital Directorate of Laboratory Medicine Fountain Street Ashton-under-Lyne Lancashire OL6 9RW Tel: 0161 331 6495 <image003.jpg> DISCLAIMER : This email and any files transmitted with it are confidential and intended solely for the use of the individual or entity to whom they are addressed. If you are not the intended recipient, please do not disclose, copy or distribute information in this email or take any action on its contents. 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